MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-19 for ZIMMER DERMATOME manufactured by Zimmer Surgical, Inc..
[186696764]
This event has been recorded by zimmer biomet under (b)(4). Once the investigation is completed, a follow-up/final report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[186696765]
It was reported that the current issue with this dermatome was believe to be a design flaw. The new models have a single locking screw on the underside of the unit to secure in the dermatome blade and protective guard plate. Due to this design, once the screw is tightened in place, there is a very clear centrally located pressure on the floppy blade which ultimately allows for normal apposition at the center of the guard, with the blade bending/bowing out at the lateral edges. The result is in varying, non-uniform depths of harvested graft take, skipping and poor cosmesis. No adverse event was reported as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001526350-2020-00292 |
| MDR Report Key | 9856982 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER SURGICAL, INC. |
| Manufacturer Street | 200 WEST OHIO AVENUE |
| Manufacturer City | DOVER OH 44622 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44622 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIMMER DERMATOME |
| Generic Name | DERMATOME |
| Product Code | GFD |
| Date Received | 2020-03-19 |
| Catalog Number | NI |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER SURGICAL, INC. |
| Manufacturer Address | 200 WEST OHIO AVENUE DOVER OH 44622 US 44622 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |